Tuesday, December 6, 2011

Unthinkable FDA Scandal Behind Soy Infant Formula

The Truth About Soy Infant Formula, A Toxic Cocktail

Infant formula is defined by law as a food for use by infants that simulates human milk or is suitable as a complete or partial substitute for human milk. During this period of rapid growth and development, nutrient requirements are greater than at any other time in life.

Infant formula is unique in comparison to almost all other foods in that it is often the sole source of nutrition in a rapidly growing and developing vulnerable population. Inadequate nutrition in infancy has the potential to result in serious and irreversible adverse effects. Thus, the importance of proper infant formula manufacture, composition, and nutrient needs cannot be overstated.

Senator Metzenbaum, in the legislative history that accompanied the 1986 Amendments to the Infant Formula Act of 1980 explained why infant formula needs more regulation than other food when he stated “There is simply no margin for error in the production of baby formula. An infant relies on the formula to sustain life and provide the proper nourishment at a time of rapid physical and mental development.”

Under 21 U.S. C. 321(z), infant formula is defined as: A food that purports to be or is represented for special dietary use solely as a food for infants by reason of its simulation of human milk or its suitability as a complete or partial substitute for human milk. Congressman Mottl stated that the 1980 act that he “is concerned with human lives at their most vulnerable stage. We are talking about food that may be the sole source of nourishment for infants.”

Under section 409 and 201(s) of the act, each ingredient added to food including infant formula must either be approved for the use as a food additive, or be Generally Recognized As Safe (GRAS) for its intended use. Safe or safety means that there is a "reasonable certainty" in the minds of competent scientists that the substance is not harmful under the intended conditions of use.

Manufacturers simply provide the FDA with, "assurances" and "reasonable certainty" that the requirements specific to infant formula have been met for each new infant formula product prior to marketing. Infant formulas are not FDA approved.

In 1965, prior to the Infant Formula Act, Mead Johnson marketed a first soy formula ProSobee, prior to GRAS status of soy. There is no "assurance" or "reasonable certainty" that soy will sustain life or provide necessary developmental nourishment. Soy is not a milk that simulates mother's milk. Soy is a toxic plant, not a milk.

Soy was first manufactured as a glue, strong enough to hold boxes together. Besides adhesives, soy is used in; resin, paints, ink, lubricants, cleaners, foam, hydraulic fluids, biodiesel.....soy foods, soy fillers, and soy infant formula. Soy foods/beverages are not proven as healthy for human consumption, and certainly not proven as healthy as a complete dietary formula/food for babies or for children. Quite the contrary.

The FDA has an in-depth file of more than 700 published studies concluding the soy phyto-toxic cause of physiological, reproductive, and neurological adverse developmental effects. For more than a decade the FDA also continues to ignore a large number of studies reported by renown scientists from the National Institute of Environmental Health Sciences (NIEHS) that conclude soy infant formula is a cause of multiple developmental adverse effects.

Soybean components are FDA known to include; estrogenic endocrine disruptors, phytic acid, inhibitor of several essential enzymes, multiple anti-nutrients, and heavy metals, of which each and even worse, all together, are especially proven as developmental poisons. These soy phyto-toxins are not found to be safe, or nutritional for use as an infant formula during this most crucial time of brain and body development. Exposure to soy phyto-toxins in combination with other known endocrine disruptors such as BPA plastics, or pesticides, equates to a highest level of developmental poison.

"Safety Assurance" is required by the Infant Formula Act, but the FDA can not "assure" that any child can survive overwhelming evidence concluding soy formula causation of mass destruction of health......severe and irreversible physiological, reproductive, and/or neurological pain and suffering as is repeatedly study reported.

The Infant Formula Act requires that the FDA monitor illnesses and injuries associated with the use of an infant formulas. In truth the FDA does not monitor soy formula illnesses or injuries caused to once healthy children, yet it is true that the FDA includes, "Soybean, Genistein, Daidzein" (soy isoflavone endocrine disruptors) on their "Poisonous Plant Database."

Without parental knowledge, healthy infants fed soy formulas are participating in an undocumented, undisclosed FDA game of adverse health roulette.

MedWatch, an FDA reporting system for adverse events, includes a long list of severe adverse effects caused by infant exposure to soy formulas as reported by parents. While refusing to post appropriate WARNING labels, the FDA is aware that infants swallowing soy infant formulas are participating in a risky health experiment, without documented follow-up.

The FDA continues to simply ignore a submitted 2009 Petition requesting WARNING labels on soy products, as well as the WITHDRAWAL of soy infant formulas. Many countries, including the U.K. and New Zealand have withdrawn soy infant formula due to evidence of adverse effects. Some countries will only prescribe soy formula as a restricted choice, with mandatory follow-up as equal to a drug, due to confirmed soy plant-poisoning adverse effects.

The United States is the largest profiteer from soy in the world. Monsanto has a large stake in the sale of soy while earning billions in profits. Monsanto also has a long, suspicious history, a "revolving door with the FDA." Currently, a prior Monsanto attorney, Michael Taylor is assistant (of food safety) to FDA Commissioner Hamburg.

It is also an injustice that physicians and hospitals rarely, if ever, question patients history of soy phyto-toxic exposure of sick infants, children.....and adults.

Infant formula is in a special category of food in which there can be no margin for error in ensuring the healthy growth and development of infants. Yet if a manufacturer testifies that they have added appropriate nutrients (to a toxin), the FDA can allow them to market their toxin as a healthy infant formula. For example, it is easy for industry to profit in the billions of dollars by marketing soy infant formulas, a plant-poison base...... with added nutrients.

There is NO valid FDA approval process for infant formulas: an independent source of nourishment that must sustain life and assure healthy body and brain development!

The FDA continues to knowingly and willingly conceal their acknowledgment of overwhelming evidence proving soy infant formulas are developmentally toxic, and can cause unnecessary physiological, reproductive, and neurological adverse health risks...... the pain and suffering of once healthy children, without parental knowledge.

Surely a worst crime in American history.

To help please visit:

http://www.petition2congress.com/4607/petition-to-protect-childrens-health

Also file your complaint with the FDA, HHS, NIH, OIG. Some day, for the pure sake of children's good health, possibly one of these U.S. health officials will actually care, and prioritize their duty to act.

(Prison inmates may have the first opportunity for soy poisoning justice. http://www.westonaprice.org/judge-gives-green-light-to-soy-lawsuit)

By; Gail Elbek Contact: gaelbek@yahoo.com